This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Voluntarily sign the informed consent form (ICF);
Male or female, ≥ 18 years and ≤ 75 years old;
Survival duration more than 3 months;
ECOG score ≤ 1 point;
Has participated in another clinical study within 4 weeks prior to the first dose;
Has previously received other immunotherapies other than PD-(L)1 inhibitors；
Other malignancies diagnosed within 5 years prior to the enrollment;
Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
Single group
SCTB41+SCTB39-1
DrugSCTB41 plus SCTB39-1 of different doses, IV, every 3 weeks
Dose-Limiting toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 21 visit
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Progression-free survival (PFS)
The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
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This trial is not recruiting at the moment. You can still explore other options:
